Argyle 8888412015Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521055490), received between Feb 5, 2019 and Aug 6, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, IT WAS FOUND THAT THE CATHETER HAD A WATER LEAK AT THE EXIT SITE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22733235 ↗
• MalfunctionFeb 5, 2024Break; Break

  ACCORDING TO THE REPORTER, WHEN DISASSEMBLING THE PERITONEAL DIALYSIS TUBE AND ACCESSORIES, IT WAS FOUND THAT THE CATHETER SHAFT (CONNECTING SHORT TUBE) WAS TEARED AND NOT THE LUER ADAPTER, WHICH WAS IMMEDIATELY REPLACED TO RESOLVE THE ISSUE AND REPORTED TO THE EQUIPMENT DEPARTMENT AFTERWARDS. PROCEDURE WAS CONTINUED AND COMPLETED. AFTER RECEIVING THE REPAIR REPORT, THE EQUIPMENT DEPARTMENT WAREHOUSE MANAGEMENT STAFF IMMEDIATELY CONTACTED THE SUPPLIER TO REPLACE IT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18647754 ↗
• MalfunctionJan 27, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING USE, THERE WAS A LEAKAGE FROM THE TUBE WHICH NEAR THE TITANIUM JUNCTION NOTED WHEN FLUSHING WAS DONE. IT WAS STATED THAT THE LEAKING SECTION WAS CUT AND CONTINUED USING THE REMAINING PIPELINE AS AN INTERVENTION TO RESOLVE THE ISSUE. THE DEVICE WAS STILL USED DESPITE THE ISSUE AND USED SUCCESSFULLY. THE TREATMENT WAS COMPLETED. THERE WAS NO OTHER PRODUCT BEING UTILIZED WITH THE DEVICE AND NOTHING UNUSUAL OBSERVED PRIOR TO USE. THERE WAS NO OTHER DEFECTS OR DAMAGES FOUND ON THE PRODUCT PRIOR TO USE. THERE WAS NO BLOOD LOSS OR BLOOD TRANSFUSION REQUIRED. NORMAL SALINE AND REGULAR ALCOHOL-FREE IODOPHOR FOR DISINFECTION WERE THE CLEANING AGENT USED TO CLEAN THE CATHETER IN ITS ENTIRETY. ALCOHOL-FREE IODOPHOR WAS UTILIZED AT THE EXIT SITE AND STERILE SERVING AS WOUND DRESSING BEING UTILIZED. WOUND DRESSING DID NOT HAVE ANY CLEANING AGENT OR ANTIMICROBIAL PROPERTIES AND NO SEPSIDERM WAS USED TO CLEAN THE CATHETERS. NO OINTMENT WAS USED AND THE CLEANING AGENTS ARE ALLOWED TO DRY THOROUGHLY PRIOR TO DRESSING THE AREA. PATIENT WAS NOT RESPONSIBLE FOR ANY TYPE OF CATHETER MAINTENANCE. CLEANING AGENTS WERE NOT SWITCHED OVER THE LIFE OF THE CATHETER TO REDUCE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11238086 ↗
• MalfunctionJun 19, 2019Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, AS THE DOCTOR PERFORMED PERITONEAL DIALYSIS CATHETERIZATION, THE PERITONEAL DIALYSIS TUBE WAS FOUND TO HAVE LEAKAGE (DIALYSATE) DURING POSTOPERATIVE EXAMINATION. AFTER THE PERITONEAL FLUID WAS FLUSHED, LEAKAGE WAS FOUND AT THE CONNECTION BETWEEN THE PERITONEAL DIALYSIS TUBE AND THE TITANIUM JOINT. IMMEDIATELY, THE PERITONEAL DIALYSIS TUBE WAS CUT SHORT AND REPLACED WITH THE EXTERNAL SHORT TUBE TO RESOLVE THE ISSUE. THERE WAS NO BLOOD LEAK AND BLOOD TRANSFUSION WAS NOT INDICATED. AS IT MAY CAUSE INFECTION TO THE PATIENT, PERITONEAL DIALYSIS FLUID WAS ADDED AND LEFT THE ABDOMEN FOR 3 DAYS TO PREVENT INFECTION. NO INFECTION HAD OCCURRED SO FAR. THE ENGINEER STATED THAT THE LEAKAGE MIGHT BE CAUSED BY THE QUALITY PROBLEM OF THE PIPELINE. IT WAS ALSO REPORTED THAT THE CLAMPS MOVED TO A NEW LOCATION AFTER TREATMENT. NO INTERVENTION/TREATMENT WAS REQUIRED DUE TO THE LEAK AND THERE WERE NO NOTICEABLE DAMAGE UPON VISUAL INSPECTION PRIOR TO USE. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8712702 ↗
• MalfunctionFeb 5, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING USE, A RUPTURE OCCURRED AT THE CONNECTION BETWEEN THE PERITONEAL TUBE AND THE EXTERNAL JOINT. IT WAS REPORTED THAT THERE WAS A LEAK AT THE JUNCTION OF THE EXTENSION TUBE AND BIFURCATE WHICH IS ALSO THE CATHETER'S SHAFT. THE DOCTOR HAD CUT-OFF THE BROKEN PART CONSIDERING THAT THE PATIENT IS STILL USING THE ABDOMINAL TUBE. INTERVENTION WAS DONE BY LETTING THE REST OF THE CATHETER PART BE USED NORMALLY, AVOIDING THE DAMAGE CAUSED TO THE PATIENT BY TUBE DRAWING AND RE-DRAWING. IT WAS STATED THAT THIS TREATMENT METHOD IS ALSO A COMMON TREATMENT METHOD AT PRESENT. THE CATHETER WAS BEING CLEANED WITHOUT USING OF DETERGENT AND OINTMENT BUT WITH USAGE OF STERILE GAUZES. THE PATIENT IS ALSO RESPONSIBLE FOR THE CATHETER MAINTENANCE LIKE CLEANING, DRESSING CHANGES, ETC. IT WAS STATED THAT THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8304756 ↗